A Study of ALS-008176 in Infants Hospitalized With RSV

• Status: Completed
• Trial end date: 2018-02-15
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alios Biopharma Inc.

Criteria

Inclusion Criteria:

• Male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the time of hospital admission, or <28 days of age (neonate cohort only). Note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an RSV related illness

Exclusion Criteria:

• Prematurity

• Receiving invasive endotracheal mechanical ventilation

• Poorly functioning gastrointestinal tract

• Anticipated to be discharged from the hospital in <24 hours from the time of randomization

• Prior exposure to palivizumab